Skip to main content
OpenTrials
Completed

NCT Number: NCT03342469

Food Additives Effects on EEG Profiles in College Students With ADHD

The purpose of this study is to examine the effects of food additives on college students with ADHD. This study could potentially answer an important question which still remains unanswered as to whether certain food additives may be able to cause cognitive and electrical activity changes in college students with and without ADHD. In this context, food additives will be artificial food coloring.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

American University

Washington D.C., District of Columbia, 20007, United States

About this study

Consent will be obtained at the first visit. Baseline data will be collected on the participants, including height, weight, computerized cognitive functioning, and an EEG recording. Participants will also be taught how to keep a detailed food and symptom diary over the following week. One week later, the participant will return to the lab and turn in the food/symptom diary. All ADHD participants and a subgroup of controls (called extended controls or EC) will be trained on how to follow the dietary intervention. Detailed information on the diet will be given, including food additives to avoid, healthy foods which should be eaten, and shopping tips. For the next two weeks, the participant will follow the dietary intervention at home with access to Dr. Holton to answer any questions. The participant will return to the lab after following the diet for two weeks and assessments (cognitive testing, and EEG) will be completed again along information on dietary compliance will be collected. The third meeting will also mark the beginning of the first challenge period. For the challenges, the participant will consume chocolate cookies every Monday, Tuesday, and Wednesday for two weeks. The cookies may or may not contain artificial food coloring depending on the week. Every Wednesday repeat testing will be completed after the cookies are consumed. The participant will be asked not to take ADHD medication on testing days. After two weeks of challenges the study will be completed. The participant will receive information on their performance and on the study results overall.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Generally good health
  • 18-24 years old
  • Currently attending college
  • Physician's diagnosis of ADHD (unless control participant)
  • Stable medication dose and frequency for 3 months before the study
  • Willing to suspend ADHD medication administration on testing day and the day after testing

Exclusion criteria

  • Presence of comorbid psychiatric condition other than comorbid depression or anxiety
  • Autism
  • Severe asthma requiring past hospitalization
  • Seizure disorder

Treatment and study plan

Artificial Food Coloring

Other

225mg mixed powdered Artificial Food Coloring (AFC)

Placebo

Other

Placebo chocolate cookies

Primary outcomes

  1. Mean Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups

    Time frame: Collected after three days exposure to AFC (on third day) and after three day exposure to placebo (on third day)

    Electroencephalography (EEG) is an objective measure of brainwave activity that non-invasively records the electrocortical activity emitted from neuronal postsynaptic outputs using small electrodes placed on the head. Quantitative EEG uses techniques to transform electrocortical voltage amplitudes into frequency bands to reflect mental processes in periodicities instead of raw values. These frequency bands can then be compared before/after treatment and/or between groups to better understand how treatment impacts the brain. Resting-state EEG was collected with eyes-closed, but awake, for four minutes

    Frequency bands assessed: delta 1-4Hz, theta 4-7Hz, alpha 8-13Hz, beta 13-30Hz, gamma 30-50Hz Each frequency band was assessed using: mean power (microvolts^2 of a frequency band divided by the length of the frequency band) a

  2. Relative Power (EEG) During AFC and Placebo Challenge in ADHD and Control Groups

    Time frame: Collected after three days exposure to AFC (on third day) and after three day exposure to placebo (on third day)

    Electroencephalography (EEG) is an objective measure of brainwave activity that non-invasively records the electrocortical activity emitted from neuronal postsynaptic outputs using small electrodes placed on the head. Quantitative EEG uses techniques to transform electrocortical voltage amplitudes into frequency bands to reflect mental processes in periodicities instead of raw values. These frequency bands can then be compared before/after treatment and/or between groups to better understand how treatment impacts the brain. Resting-state EEG was collected with eyes-closed, but awake, for four minutes

    Frequency bands assessed: delta 1-4Hz, theta 4-7Hz, alpha 8-13Hz, beta 13-30Hz, gamma 30-50Hz Each frequency band was assessed using: relative power (sum of microvolts^2 of a frequency band divided by total power to get a percent)

  3. ADHD Symptoms During AFC and Placebo Challenge in ADHD and Control Groups

    Time frame: Collected after three days exposure to AFC (on third day) and after three day exposure to placebo (on third day)

    Name: Adult ADHD Self-Report Scale-V1.1 Construct: Self-report checklist of adult ADHD symptoms to screen for possibility of ADHD. It is not meant to be diagnostic. According to the documentation, "The questions in the ASRS v1.1 are consistent with DSM-IV criteria and address the manifestations of ADHD symptoms in adults." Total Range: 0-72 points - higher score indicates more and/or higher frequency of adult ADHD symptoms

    Sub-scores:

    • Inattentive: sum of number/frequency of nine questions (taken from full ASRS questionnaire) related to inattention Range: 0-36 - higher score indicates more and/or higher frequency of inattention symptoms
    • Hyperactive: sum of number/frequency of nine questions (taken from full ASRS questionnaire) related to hyperactivity Range: 0-36 - higher score indicates more and/or higher frequency of hyperactivity symptoms

Sponsors and collaborators

Lead sponsor

American University

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 17, 2017
Registry last updated
Sep 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.